• Biomolecules & Therapeutics
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• 제6권3호
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• pp.312-316
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• 1998

Efficacy and in vivo bioassay of recombinant human erythropoietin (rho-EPO), was investigated. Efficacy studies were conducted in normal, and cisplatin-induced anemic rats. Normal and anemic animals were treated intravenously with rhu-EPO for 5 days, and the changes in the number of red blood cells (RBC), hemoglobin concentration (Hb), hematocrit value (Hct) and percentage reticulocyte value (Ret, reticulocyte/RBC) were examined. In normal rats, rho-EPO significantly increased RBC, Hb, Hct and Ret at the doses of 50∼ 1,250 lU/kg/day in a dose-dependent fashion. Cisplatin-induced anemic rats showed significant increase of RBC, Hb, Hct and Ret after administration of rho-EPO (50-200 lU/kg/day) in a dose-dependent manner. These changes of hematological parameters disappeared gradually after cessation of the treatment. The in vivo bioassay results in polycythemic mice showed that rho-EPO had 90% of bioactivity compared to NIBSC standard rhu-EPO. These results suggest that rho-EPO might be useful for the therapy of anemia originated from renal failure and chemotherapy-induced anemia.

• Toxicological Research
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• 제14권3호
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• pp.393-400
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• 1998

As a series of safety studies on DA-3585, a recombinant human erythropoietin, its local irritancy was examined in rabbits after the following treatments; application into the conjunctival sac of the eye(single), subcutaneous injection (single and -day repeated)and intravenous injection (7-day repeated.)In addition, perivascular irritation of DA-3585 was investigated in mice. In the result of ocular irritation test, 10,000IU/ml solution of DA-3585 could be considered as a non-irritating material. The local irritation of DA-3585 by a single and 7-day repeated subcutaneous injection was negligible and not so much different from that of saline. In the vascular irritancy test, macro-and microscopic observations revealed that local irritation of DA-3585 was comparable to that of saline when injected into retroauricular vein of rabbits for 7 consecutive days. Furthermore the perivascular administration of DA-3585 upto the concentration of 10,000 IU/ml did not induce any morphological abnormalities at injection sites. The results obtained from the present study suggest that the local irritancy of DA-3585 is not different from that of saline when injected through intravenous or subcutaneous route for clinical practice.